MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP PAC, DISPOSABLE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 7209874

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).One hip pac, disposable device (in two pieces) was returned for evaluation.Under 40x magnification it was noted that break point; the break itself is flexed at a 45 degree angle.This may indicate contact with an ancillary device.It was also noted that there are no microscopic voids in the material.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review has not identified additional complaints for this lot number on file.We are unable to determine the cause of the failure.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

During a hip arthroscopy using the hip pac, disposable the guidewire snapped during insertion into patient's hip joint.The snapped off section of guidewire was retrieved.No patient injury or other complications were reported.

• Brand Name: HIP PAC, DISPOSABLE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5965075
• MDR Text Key: 55571442
• Report Number: 1219602-2016-00757
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 7209874
• Device Lot Number: 50478953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR